Patient-reported outcome measures (PROMs) are being used increasingly in total knee arthroplasty (TKA). We conducted a systematic review aimed at identifying psychometrically sound PROMs by appraising their measurement properties. Studies concerning the development and/or evaluation of the measurement properties of PROMs used in a TKA population were systematically retrieved via PubMed, Web of Science, Embase, and Scopus. Ratings for methodological quality and measurement properties were conducted according to updated COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Of the 155 articles on 34 instruments included, nine PROMs met the minimum requirements for psychometric validation and can be recommended to use as measures of TKA outcome: Oxford Knee Score (OKS); OKS–Activity and Participation Questionnaire (OKS-APQ); 12-item short form Knee Injury and Osteoarthritis Outcome (KOOS-12); KOOS Physical function Short form (KOOS-PS); Western Ontario and McMaster Universities Arthritis Index-Total Knee Replacement function short form (WOMAC-TKR); Lower Extremity Functional Scale (LEFS); Forgotten Joint Score (FJS); Patient’s Knee Implant Performance (PKIP); and University of California Los Angeles (UCLA) activity score. The pain and function subscales in WOMAC, as well as the pain, function, and quality of life subscales in KOOS, were validated psychometrically as standalone subscales instead of as whole instruments. However, none of the included PROMs have been validated for all measurement properties. Thus, further studies are still warranted to evaluate those PROMs. Use of the other 25 scales and subscales should be tempered until further studies validate their measurement properties. Cite this article: Bone Joint Res 2021;10(3):203–217

Aims. To estimate the measurement properties for the Oxford Knee Score (OKS) in patients undergoing revision knee arthroplasty (responsiveness, minimal detectable change (MDC-90), minimal important change (MIC), minimal important difference (MID), internal consistency, construct validity, and interpretability). Methods. Secondary data analysis was performed for 10,727 patients undergoing revision knee arthroplasty between 2013 to 2019 using a UK national patient-reported outcome measure (PROM) dataset. Outcome data were collected before revision and at six months postoperatively, using the OKS and EuroQol five-dimension score (EQ-5D). Measurement properties were assessed according to COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines. Results. A total of 9,219 patients had complete outcome data. Mean preoperative OKS was 16.7 points (SD 8.1), mean postoperative OKS 29.1 (SD 11.4), and mean change in OKS + 12.5 (SD 10.7). Median preoperative EQ-5D index was 0.260 (interquartile range (IQR) 0.055 to 0.691), median postoperative EQ-5D index 0.691 (IQR 0.516 to 0.796), and median change in EQ-5D index + 0.240 (IQR 0.000 to 0.567). Internal consistency was good with Cronbach’s α 0.88 (baseline) and 0.94 (post-revision). Construct validity found a high correlation of OKS total score with EQ-5D index (r = 0.76 (baseline), r = 0.83 (post-revision), p < 0.001). The OKS was responsive with standardized effect size (SES) 1.54 (95% confidence interval (CI) 1.51 to 1.57), compared to SES 0.83 (0.81 to 0.86) for the EQ-5D index. The MIC for the OKS was 7.5 points (95% CI 5.5 to 8.5) based on the optimal cut-off with specificity 0.72, sensitivity 0.60, and area under the curve 0.66. The MID for the OKS was 5.2 points. The MDC-90 was 3.9 points. The OKS did not demonstrate significant floor or ceiling effects. Conclusion. This study found that the OKS was a useful and valid instrument for assessment of outcome following revision knee arthroplasty. The OKS was responsive to change and demonstrated good measurement properties. Cite this article: Bone Joint J 2021;103-B(4):627–634

Objectives. Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods. A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results. In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties. Conclusion. According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties. Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153–161. DOI: 10.1302/2046-3758.54.2000462

Aims. A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. Methods. A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders. Results. The Wales Lower Limb Trauma Recovery scale was identified, demonstrating validation evidence in the target population. In addition, ten candidate OMIs met the shortlisting criteria. Six patients, eight healthcare professionals, and 11 research methodologists attended the consensus meeting. Consensus was achieved for the EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and the Lower Extremity Functional Scale (LEFS) to measure ‘Quality of life’ and ‘Walking, gait and mobility’ in future research trials, audit, and clinical assessment, respectively. No instrument met consensus criteria to measure ‘Being able to return to life roles’ and ‘Pain or discomfort’. However, the EQ-5D-5L was found to demonstrate good face validity and could also be used pragmatically to measure these two outcomes, accepting limitations in sensitivity. Conclusion. This study recommends the LEFS and EQ-5D-5L to measure the core outcome set for adult open lower limb fracture. Cite this article: Bone Joint Res 2023;12(6):352–361

Background to the study. The use of Patient Reported Outcome Measures (PROMs) to measure effectiveness of care, and supporting patient management is being advocated increasingly. When evaluating outcome it is important to identify a PROM with good measurement properties. Purpose of the study. To review the measurement properties of the low back and neck versions of the Bournemouth Questionnaire. Methods. Bibliographic databases (e.g. EMBASE, MEDLINE, CINAHL and PsycInfo) were searched for articles evaluating the measurement properties of the Bournemouth Questionnaire. Articles were excluded that did not evaluate measurement properties of this instrument. The methodological quality of the studies selected was evaluated using the COSMIN checklist with the four point rating scale. Studies were rated as “excellent”, “good”, “fair” or “poor” based on completion of the checklist. Results. The initial search produced 6265 hits. A total of 13 studies were included in the final evaluation. Seven studies used the Bournemouth Questionnaire neck version, and six studies involved the back version. Cross-cultural translation was reported in six studies, reliability data were reported in eight studies, and responsiveness in ten studies. Conclusion. The review's findings suggest that the Bournemouth Questionnaire has suitable measurement properties for benchmarking practice in musculoskeletal settings. Conflicts of interest. None. Sources of funding. This study was sponsored by the National Council for Osteopathic Research (. www.ncor.org.uk. )

Researchers and clinicians measuring outcomes following total ankle replacement (TAR) are challenged by the wide range of outcome measures used in the literature without consensus as to which are valid, reliable, and responsive in this population. This review identifies region- or joint-specific outcome measures used for evaluating TAR outcomes and synthesises evidence for their measurement properties. A standard search strategy was conducted of electronic databases MEDLINE, EMBASE and CINAHL (to June 2015) to identify foot/ankle measures in use. A best evidence synthesis approach was taken to critically appraise measurement properties [COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)] of identified measures. The review was restricted to English publications and excluded cross-cultural adaptations. Measurement properties collected from each article were coded for validity, reliability, responsiveness, or interpretability. Clinimetric evidence exists for identified measures tested in non-TAR populations, but were not the focus of this review. The search identified 14 studies to include in the best evidence synthesis with 32 articles providing clinimetric evidence for eight of the measures (one CBO, seven PRO), however only five measures were tested in a TAR population (Foot Function Index, Ankle Osteoarthritis Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale [AOFAS], Foot and Ankle Outcome Score, Self-Reported Foot and Ankle Score). Five studies provided clinimetric evidence in a TAR population and their methodological quality was assessed: (1) Validity—two good quality studies examining different measures provide moderate evidence supporting construct validity (FFI, AOS, AOFAS self-reported items; SEFAS); (2) Reliability—two good quality studies examining different measures provide moderate evidence supporting internal consistency and test-retest reliability (FFI, AOS, AOFAS self-reported items; FAOS, SEFAS); (3) Responsiveness—three poor quality studies, thus unknown evidence for responsiveness; (4) Interpretability—two studies provide interpretability values (AOS, FFI, AOFAS self-reported items; AOS). This review offers a basis for choosing the most appropriate instrument for evaluating TAR outcomes. Numerous outcome measures were identified with evidence supporting their use in populations with various foot/ankle conditions, but none have strong evidence supporting use in a TAR population. Measures must have adequate clinimetric properties in all patient groups in which they are applied. Evidence supporting or critiquing an instrument should not be based on studies with poor quality methodology, as identified by this review. Further testing in a TAR population would benefit identified measures with emphasis on adequate sample sizes, testing a priori hypotheses, and evaluating their content validity for a TAR population

Objectives. The patient-rated wrist evaluation (PRWE) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are patient-reported outcome measures (PROMs) used for clinical and research purposes. Methodological high-quality clinimetric studies that determine the measurement properties of these PROMs when used in patients with a distal radial fracture are lacking. This study aimed to validate the PRWE and DASH in Dutch patients with a displaced distal radial fracture (DRF). Methods. The intraclass correlation coefficient (ICC) was used for test-retest reliability, between PROMs completed twice with a two-week interval at six to eight months after DRF. Internal consistency was determined using Cronbach’s α for the dimensions found in the factor analysis. The measurement error was expressed by the smallest detectable change (SDC). A semi-structured interview was conducted between eight and 12 weeks after DRF to assess the content validity. Results. A total of 119 patients (mean age 58 years (. sd. 15)), 74% female, completed PROMs at a mean time of six months (. sd. 1) post-fracture. One overall meaningful dimension was found for the PRWE and the DASH. Internal consistency was excellent for both PROMs (Cronbach’s α 0.96 (PRWE) and 0.97 (DASH)). Test-retest reliability was good for the PRWE (ICC 0.87) and excellent for the DASH (ICC 0.91). The SDC was 20 for the PRWE and 14 for the DASH. No floor or ceiling effects were found. The content validity was good for both questionnaires. Conclusion. The PRWE and DASH are valid and reliable PROMs in assessing function and disability in Dutch patients with a displaced DRF. However, due to the high SDC, the PRWE and DASH are less useful for individual patients with a distal radial fracture in clinical practice. Cite this article: Y. V. Kleinlugtenbelt, R. G. Krol, M. Bhandari, J. C. Goslings, R. W. Poolman, V. A. B. Scholtes. Are the patient-rated wrist evaluation (PRWE) and the disabilities of the arm, shoulder and hand (DASH) questionnaire used in distal radial fractures truly valid and reliable? Bone Joint Res 2018;7:36–45. DOI: 10.1302/2046-3758.71.BJR-2017-0081.R1

Aims. To validate the English language Forgotten Joint Score-12 (FJS-12) as a tool to evaluate the outcome of hip and knee arthroplasty in a United Kingdom population. Patients and Methods. All patients undergoing surgery between January and August 2014 were eligible for inclusion. Prospective data were collected from 205 patients undergoing total hip arthroplasty (THA) and 231 patients undergoing total knee arthroplasty (TKA). Outcomes were assessed with the FJS-12 and the Oxford Hip and Knee Scores (OHS, OKS) pre-operatively, then at six and 12 months post-operatively. Internal consistency, convergent validity, effect size, relative validity and ceiling effects were determined. Results. Data for the TKA and THA patients showed high internal consistency for the FJS-12 (Cronbach α = 0.97 in TKAs, 0.98 in THAs). Convergent validity with the Oxford Scores was high (r = 0.85 in TKAs, r = 0.79 for THAs). From six to 12 months, the change was higher for the FJS-12 than for the OHS in THA patients (effect size d = 0.21 versus -0.03). Ceiling effects at one-year follow-up were low for the FJS-12 with just 3.9% (TKA) and 8.8% (THA) of patients achieving the best possible score. Conclusion. The FJS-12 has strong measurement properties in terms of validity, internal consistency and sensitivity to change in TKA and THA patients. Low ceiling effects and good relative validity allow the monitoring of longer term outcomes, particularly in well-performing groups after total joint arthroplasty. Cite this article: Bone Joint J 2017;99-B:218–24

Objectives. To study the measurement properties of a joint specific patient reported outcome measure, a measure of capability and a general health-related quality of life (HRQOL) tool in a large cohort of patients with a hip fracture. Methods. Responsiveness and associations between the Oxford Hip Score (a hip specific measure: OHS), ICEpop CAPability (a measure of capability in older people: ICECAP-O) and EuroQol EQ-5D (general health-related quality of life measure: EQ-5D) were assessed using data available from two large prospective studies. The three outcome measures were assessed concurrently at a number of fixed follow-up time-points in a consecutive sequence of patients, allowing direct assessment of change from baseline, inter-measure associations and validity using a range of statistical methods. Results. ICECAP-O was not responsive to change. EQ-5D was responsive to change from baseline, with an estimated standardised effect size for the two datasets of 0.676 and 0.644 at six weeks and four weeks respectively; this was almost as responsive to change as OHS (1.14 at four weeks). EQ-5D correlated strongly with OHS; Pearson correlation coefficients were 0.74, 0.77 and 0.70 at baseline, four weeks and four months. EQ-5D is a moderately good predictor of death at 12 months following hip fracture. Furthermore, EQ-5D reported by proxies (relatives and carers) behaves similarly to self-reported scores. Conclusions. Our findings suggest that a general HRQOL tool such as EQ-5D could be used to measure outcome for patients recovering from hip fracture, including those with cognitive impairment. Cite this article: Bone Joint Res 2014;3:69–75

The patient-reported Manchester-Oxford Foot Questionnaire (MOXFQ), with 3 dimensions (Walking/standing(W/S), Pain, Social interaction(SI)) has previously been validated in patients undergoing hallux valgus surgery. A preliminary cross-sectional evaluation of its measurement properties relating to surgery on different regions of the foot and ankle is presented here. Within 4 weeks prior to foot or ankle surgery, 671of 764 consecutive eligible patients (87.8% response rate) were assessed with the: (i) MOXFQ questionnaire, (ii) SF-36 general health survey (iii) American Orthopaedic Foot & Ankle Society (AOFAS) scales. Sample characteristics: mean age 53 years 427 (63.6%) female. Patients were booked for (main) surgery on Hallux (210, 31.3%), Lesser Toes (119, 17.7%), Mid foot (22, 3.3%), Ankle/Hind foot (311, 46.3%) and whole foot/multiple regions (9, 1.3%). MOXFQ item response rates were high (<2% missing on any one item) with responses generally well distributed across response categories. Item-total correlations within each dimension were generally above recommended levels. Internal consistency, as assessed by Cronbach's alpha, were 0.93, 0.84 and 0.71 for the W/S, Pain and SI dimensions, respectively. Within Hallux, Lesser toes and Ankle/hind foot surgical subgroups (low numbers precluded mid foot and whole/multiple region analyses), alphas for these subscales were similar. Convergent validity of MOXFQ was demonstrated by correlations between the 3 dimensions (W/S, Pain, SI) with similar dimensions of the SF-36 and relevant AOFAS scales. A priori hypotheses were generally supported. The MOXFQ demonstrates good baseline measurement properties in patients undergoing a range of foot and ankle surgery, suggesting its suitability as an outcome measure for clinical trials of foot and ankle surgery in general. The SI dimension, concerned with cosmesis and social participation has somewhat weaker properties but remains useful. Evidence for the MOXFQ's responsiveness across the range of foot and ankle surgery is yet to be assessed

Purpose: The purpose of this study was to examine the measurement properties of four commonly used disability measures. We hypothesized that all measures would have a high (0.8 or > 0.8) internal consistency and ability to discriminate between men and women’s level of disability. A moderate convergent validity (0.5 to 1.00). Method: This was a prospective longitudinal study of patients with advanced primary osteoarthritis of glenohumeral joint who underwent a Total Shoulder Arthroplasty (TSA). Four measures [Western Ontario Osteoarthritis Shoulder (WOOS) Index, the American Shoulder and Elbow Surgeon’s (ASES) assessment, Constant-Murley Score (CMS), and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH)] were completed 2–3 weeks before surgery and at 6 months after surgery. The measurement properties were examined in:. internal consistency as a measure of reliability,. cross-sectional and longitudinal convergent validity,. known group validity, and. sensitivity to change at 6 months following surgery. Analysis involved calculating Cronbach Coefficient Alpha to measure internal consistency. Convergent validity was examined by the Pearson correlation coefficient. Analysis of Variance examined the extent of known group validity. The Standardized Response Mean (SRM) was used to measure the relative sensitivity to change. Results: Seventy patients (mean age: 65, range: 35–86, 44 females, 26 males) participated in the study. The Cronbach Coefficient Alpha was high at 0.91, 0.86, and 0.83 for WOOS, ASES, and QuickDASH respectively. Cross-sectional convergent validity was moderate with correlations varying from 0.54 to 0.79. Longitudinal convergent validity ranged from 0.58 to 0.88. All measures were able to discriminate between men and women at p< 0.05 with Cohen’s d of 1.07, 0.85, 0.82, and 0.55 for QuickDASH, CMS, WOOS, and ASES respectively. The SRM was 2.41, 2.17, 1.88, and 1.63 for WOOS, CMS, ASES and QuickDASH respectively. Conclusion: All four disability measures were valid and reliable in candidates for TSA. The WOOS, a disease-specific outcome demonstrated a higher reliability and sensitivity to change than other measures. QuickDASH had a better ability to differentiate between men and women. Clinicians may not gain additional information by administrating multiple similar outcome measures. Researchers will decrease their chance of declaring a statistical significance by choosing one primary outcome measure

Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

Aims

To map the Oxford Knee Score (OKS) and High Activity Arthroplasty Score (HAAS) items to a common scale, and to investigate the psychometric properties of this new scale for the measurement of knee health.

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To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.

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The Single Assessment Numerical Evalution (SANE) score is a pragmatic alternative to longer patient-reported outcome measures (PROMs). The purpose of this study was to investigate the concurrent validity of the SANE and hip-specific PROMs in a generalized population of patients with hip pain at a single timepoint upon initial visit with an orthopaedic surgeon who is a hip preservation specialist. We hypothesized that SANE would have a strong correlation with the 12-question International Hip Outcome Tool (iHOT)-12, the Hip Outcome Score (HOS), and the Hip disability and Osteoarthritis Outcome Score (HOOS), providing evidence for concurrent validity of the SANE and hip-specific outcome measures in patients with hip pain.

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Periprosthetic proximal femoral fractures (PFFs) are a major complication after total hip arthroplasty (THA). Health status after PFF is not specifically investigated. The aim of this study is to evaluate the health status pattern over two years after sustaining a PFF.

We developed a questionnaire to assess patient-reported outcome after surgery of the elbow from interviews with patients. Initially, 17 possible items with five response options were included. A prospective study of 104 patients (107 elbow operations) was carried out to analyse the underlying factor structure, dimensionality, internal and test-retest reliability, construct validity and responsiveness of the questionnaire items. This was compared with the Mayo Elbow performance score clinical scale, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short-Form (SF-36) General Health Survey. In total, five questions were considered inappropriate, which resulted in the final 12-item questionnaire, which has been referred to as the Oxford elbow score. This comprises three unidimensional domains, ‘elbow function’, ‘pain’ and ‘social-psychological’; with each domain comprising four items with good measurement properties. This new 12-item Oxford elbow score is a valid measure of the outcome of surgery of the elbow

Background to the study:. The use of Patient Reported Outcome Measures (PROMs) is being increasingly advocated but data are still being collected using paper systems. This is costly and environmentally challenging. New innovations are required to balance the challenges of capturing PROM data while considering budgets, and access to IT, and patient choice. Purpose of the study:. To develop and test a mobile phone and web app for collecting patient reported outcomes about musculoskeletal symptoms. Methods:. The content of the app was developed following qualitative work with patients and clinicians, and a review of measurement properties of different PROMs. Early versions of the app underwent α- and β-testing to identify issues with functionality. The PROM app was pilot-tested to assess feasibility, responsiveness, and test-retest reliability of the PROMs. The pilot version of the app contained demographic data, the Roland Morris Disability Questionnaire (RMDQ), the Bournemouth Questionnaire, and Visual Analogue Scale for pain. At follow-up additional questions exploring patient satisfaction and experience of care, plus a transition question were asked. Results:. A total of 517 patient codes were allocated. Completed datasets were gathered from patients (N=92) potentially indicating issues with acceptability and feasibility. Data analysis indicated good completion of questions. The RMDQ appeared to be largely redundant in this patient population and was removed in the final version of the app. Conclusion:. The app performed well when used by participants. Support is required for practitioners and patients to implement this electronic data capture system

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The aim of this study was to report the meaningful values of the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) and EuroQol visual analogue scale (EQ-VAS) in patients undergoing primary knee arthroplasty (KA).